Gastroesophageal reflux disease (GERD) refers to difficult symptoms or mucosal damage caused due to the reflux of gastric content into the esophagus. It is one of the most common gastrointestinal tract disorders and prevails globally with estimates higher than 33 % in Asia and the Middle East, 21% in Europe, and 28% in the U.S.A. The two main forms of GERD are defined as NERD (Non-Erosive Reflux Disease) and ERD (Erosive Reflux Disease). Between the two, NERD represents up to 70% of the patients suffering from typical reflux symptoms. Further, these patients have a low response rate towards PPI therapy (Proton Pump Inhibitor).
A recent clinical trial assessed RefluG™ Isorepair in patients with NERD. It is a novel patent-pending mixture of liquid sachets registered in Europe as Medical Device Class IIA. The study is a considerable contribution to the Gastroesophageal Reflux Disease Therapeutics Market as it contributes towards checking the efficacy of this device. This is important as the research put forth that the product has a protective effect and favors the mucosa's natural light, leading to a decrease in disagreeable symptoms related to acid reflux.
The effectiveness and tolerability of RefluG™ Isorepair have been checked in a completely random, double-blind placebo-controlled trial that revolved around 40 NERD patients. For the trial, patients were divided into treatment groups, with some receiving placebo and others receiving RefluG™ Isorepair. The latter group received three sachets per day after main meals or before bed.
The trial revealed that there was a 3-point decrease in TSS (Total Symptoms Score). This was successfully achieved by 95% of patients treated with the new product, whereas only 20% of the patients that received placebo showcased a 3-point reduction. Furthermore, patients in the RefluG™ Isorepair also showed a 68% decrease in TSS by the end of the treatment in contrast with baseline.
As per the Heartburn severity index, it was statically lower in patients who received the investigational product than those who received placebo (both were tested for seven days). Also, the clinical trial concluded that the quality of life for patients in the RefluG™ Isorepair was much better than placebo group patients. Overall, the investigational product was found to be safe and well-tolerated with no adverse effects.
The new product has the ability to strengthen the esophageal barrier against the damage brought on by gastric contents that flow back into the esophagus in between reflux episodes. By looking at the mechanism of the product, it could potentially be used alone or in combination with other pharmacological interventions so that GERD could be better managed.
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